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Re: DewDiligence post# 181657

Thursday, 09/04/2014 11:31:52 PM

Thursday, September 04, 2014 11:31:52 PM

Post# of 251811
LLY's peglispro: Look at its safety profile compared to Lantus:


Results of these two trials also showed patients taking BIL experienced changes in lipid parameters, including a small but statistically significant increase in triglycerides in both trials. In IMAGINE-3, there were small but statistically significant reductions and increases, respectively, in HDL (high-density lipoprotein) cholesterol and LDL (low-density lipoprotein) cholesterol in patients taking BIL compared with those taking insulin glargine. In addition, IMAGINE-3 showed patients taking BIL experienced small but statistically significant increases in systolic and diastolic blood pressure compared to insulin glargine (less than 2 mmHg mean difference at 52 weeks). Statistically significant differences in HDL and LDL cholesterol and blood pressure were not observed in IMAGINE-1. There were no major adverse cardiac events (MACE) in IMAGINE-1, and in IMAGINE-3, the MACE+ (cardiovascular death, non-fatal stroke, non-fatal MI and hospitalization due to unstable angina) event rate was lower for patients taking BIL compared with those taking insulin glargine.

In both trials, treatment with BIL was associated with a statistically significant higher incidence of patients with greater than three times the upper limit of normal range in the liver enzyme ALT (alanine aminotransferase) compared with patients taking insulin glargine. No cases of severe liver injury (Hy's Law) occurred in either of the trials. In a subset of patients whose liver fat was measured using MRI imaging, BIL-treated patients had a statistically significant increase in liver fat compared to insulin glargine.

In both trials, there were significantly more injection site reactions observed in patients taking BIL compared to those taking insulin glargine.

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